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510(k) Data Aggregation

    K Number
    K241995
    Device Name
    HyperFlex™ Bunion Correction System
    Manufacturer
    Date Cleared
    2024-11-26

    (140 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    FootBridge Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FootBridge Medical HyperFlex™ Bunion Correction System is intended for use in reconstruction (correction) of the hallux valgus deformity by holding the reduction of the 1st metatarsal intermetatarsal (IM) angle in adults and pediatric patients aged ≥13 years in which growth plates have fused.
    Device Description
    The FootBridge Medical HyperFlex™ Bunion Correction System is an implantable device and accompanying instrumentation used to treat a hallux valgus deformity (bunion). It includes components that attach to the 1st and 2nd metatarsals which are joined by a suture. The system reduces the IM angle between the 1st and 2nd metatarsal without restricting range of motion in the sagittal plane. The implant will be offered in several sizes to fit the anatomical needs of the patient population.
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